Abbott Tendyne Gebrauchsanweisung Seite 23

7. Loading Handle Extension Tube
8. Loading Handle
9. 1-way Stopcock (not shown)
10. 3-way Stopcock (not shown)
11. Tuohy-Borst with extension (not shown)
2. Attach the Loading Tube to the Loading Funnel.
Ensure the Loading Tube black indicator and
Funnel cutout indicator are aligned. Ensure the
interfacing keys are aligned and the interfacing
O-ring is fully seated.
3. Feed the tether through the Loading Funnel
and Loading Tube until the valve is seated
inside the Loading Funnel. Approximately
align the anterior aspect of the valve cuff
(raised portion) to the Loading Funnel cutout
(Figure 13).
4. Attach the Closed Cap onto Loading Funnel.
5. Attach the Closed Cap Extension Tube to the
Closed Cap and attach a 1-way stopcock to the
free end of the Closed Cap Extension Tube.
6. Mount the Loading Funnel, Loading Tube, and
Closed Cap into the stand clips oriented with
the Closed Cap down (in Bottom Loading Clip -
Clip 2) and the Loading Tube up (in Rotating
Clip - Clip 1). Make sure that the black
alignment indicators are visible.
7. Hang a 1000 mL saline bag pressurized to 150 –
250 mmHg and attach the fluid line to the
Closed Cap/Closed Cap Extension Tube
assembly. Make sure that all luer connections
are tight and secure.
8. Fill the assembly with saline up to a level even
with the open end of the Loading Tube and
shut the 1-way stopcock.
9. Tap the Loading Funnel and Loading Tube to
remove any air bubbles behind the valve.
10. Attach a Tuohy-Borst with extension to the
Loading Handle Extension Tube, then attach
a 3-way stopcock to the side port tubing luer
on the Tuohy-Borst valve.
TM
IFU, TENDYNE Mitral Valve System
Figure 12. Tendyne™ Loading Handle.
1. Loading Handle Knob
2. Knob Retention Thumb Screw (not shown, behind
Loading Handle Knob)
11. Verify that the line on the Loading Handle Knob
and the line on the Loading Handle are aligned.
The Loading Handle Knob can be rotated until
the two (2) are aligned.
12. Assure that the Tuohy-Borst valve is open. If
closed, turn the rotator in the counter-
clockwise direction to open the valve.
13. Thread the tether through the Loading Handle,
ensuring the side of the Loading Handle with
the knob is aligned with the black indicator line
on the Loading Tube.
14. Attach the Loading Handle to Loading Tube.
15. Use the saline bag to continue filling the
remainder of the Loading System until saline
exits the Loading Handle Extension Tube and
fittings. If leaks are observed, reconfirm keying
of Loading Handle.
16. Close the Tuohy-Borst valve and all stopcocks.
17. Turn off the flush and remove the saline line
from the Closed Cap Extension Tube.
18. Invert Loading System and secure to the stand
by securing the Loading Tube into the Rotating
Clip - Clip 1 and Loading Handle into the
Bottom Loading Clip - Clip 2.
19. Remove Closed Cap from assembly.
20. Place the Tether Clip onto the tether leader at
the end of the Tuohy-Borst valve.
21. Apply tension to the tether leader and slide the
Tether Clip into contact with the Tuohy-Borst
valve.
22. Use syringe with de-air (air evacuation) tube to
remove air from the valve pockets.
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